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Gupta Rounded Lumbar Pedicle Probe
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5005-05Ref 5005-06
Identity
- Trade Name
- Gupta Rounded Lumbar Pedicle Probe EUDAMEDGupta Pediatric Pedicle Probe EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Endoscopic surgical probe FDA UDI
- Device Name
- Probe EUDAMEDGupta Rounded Lumbar Pedicle Probe FDA UDI
- Model / Reference
- 5005-05 EUDAMED5005-06 EUDAMEDFDA UDI
- Description
- Gupta Rounded Lumbar Pedicle Probe FDA UDI
Identifiers
- Catalog Number
- 5005-06 FDA UDI
- Primary DI / UDI-DI
- 00840277129291 EUDAMEDFDA UDI00840277129307 EUDAMED
- Basic UDI-DI
- 8402771INNOPROBE0133 EUDAMED
- Direct Marketing DI
- 00840277129291 EUDAMED00840277129307 EUDAMED
- FDA Product Code
- HXB FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endoscopic surgical probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gupta Rounded Lumbar Pedicle Probe by Innomed, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8402771INNOPROBE0133 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (3)
- EUDAMED 38b638da-98c2-4490-9543-4235455d8107 61 fields · synced Jun 18, 2026
- EUDAMED e32d7cfa-cd37-4a6a-a3d2-7d9dde365dcd 61 fields · synced May 18, 2026
- FDA UDI 40059964-5e1e-4bad-b59b-aab0d26a57db 34 fields · synced May 26, 2026